CIRON DRUGS AND PHARMACEUTICALS PVT LTD
Form 483 issued April 25, 2023 · Tarapur, India
- Inspection
- Apr 17 – Apr 25, 2023
- Investigator
- Bijoy Panicker
- Observations
- 2
- Pages
- 3
- FEI number
- 3017545500
In short: On April 25, 2023, FDA issued a Form 483 with 2 observations to CIRON DRUGS AND PHARMACEUTICALS PVT LTD in Tarapur, Maharashtra (FEI 3017545500) after an inspection that ran Apr 17 – Apr 25, 2023. The investigator was Bijoy Panicker. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
In-process materials are not tested for identity, strength, quality and purity and approved or rejected by…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmCIRON DRUGS AND PHARMACEUTICALS PVT LTD history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CIRON DRUGS AND PHARMACEUTICALS PVT LTD?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected CIRON DRUGS AND PHARMACEUTICALS PVT LTD?
Bijoy Panicker is named on this Form 483, for the inspection of Apr 17 – Apr 25, 2023. Each investigator has a profile showing what they cite most.
When was CIRON DRUGS AND PHARMACEUTICALS PVT LTD inspected by FDA?
The inspection ran Apr 17 – Apr 25, 2023, and the Form 483 is dated April 25, 2023.
How do I get the full Form 483 for CIRON DRUGS AND PHARMACEUTICALS PVT LTD?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.